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                <term xml:lang="en">Non-pharmacological interventions</term>
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              <classCode scheme="mesh">non-pharmacological intervention</classCode>
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              <p>BackgroundThe term non-pharmacological interventions (NPIs) refers to health prevention and care protocols predominantly with a physical, nutritional or psychosocial focus supervised by a healthcare professional. Unlike drugs and medical devices, no consensual model for evaluating these complex interventions existed prior to the present study because of the heterogeneity in intervention content and study protocols. This heterogeneity limited the transferability of good practices and led to a great deal of mistrust in NPIs among professionals and healthcare users alike. The present study involved the co-construction of a consensual framework for the evaluation of NPIs, which meets both the specificity of these types of interventions and international standards for research in the field of health.MethodThe study involved all concerned stakeholders in France, including academic and non-academic, researchers, healthcare users, health practitioners, health operators, scientific societies and health authorities. The framework was co-constructed under the direction of a multidisciplinary committee of 22 experts through iterative, open and tracked exchanges, in four successive stages: work performed by a select committee, work performed by a larger committee, open vote by college, and finally, consultation with health authorities and scientific societies.ResultsThe framework for evaluating NPIs, called the ‘NPI Model’, includes 14 ethical invariants and 63 methodological invariants distributed between five types of study: mechanistic, observational, prototypical, intervention, and implementation. It received the support of 28 scientific societies and three French health authorities.ConclusionThe creation of a standardized framework for evaluating NPIs in the French context has several advantages, as follows: i) it harmonises and clarifies epistemological, methodological and ethical expectations of NPI evaluation studies for researchers; ii) it ensures greater transferability of study results to real-world clinical use of the relevant NPI; iii) it guarantees that programs for professionals in the healthcare, prevention and social assistance sectors are more operational; iv) it facilitates efficient and safer practices for healthcare users; v) it helps to provide decision-makers and regulators with a greater understanding of NPIs; vi) it ensures more traceable interventions for health operators; vii) it provides solutions that can be better integrated into the financing strategies of insurance and social solidarity systems.</p>
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            <abstract xml:lang="fr">
              <p>Le terme d'interventions non médicamenteuses (INM) fait référence aux protocoles de prévention santé et de soins à dominante corporelle, nutritionnelle ou psychosociale et supervisés par un professionnel de la santé. Contrairement aux médicaments et aux dispositifs médicaux, aucun modèle consensuel d'évaluation de ces interventions complexes n'existait avant cette étude en raison de l'hétérogénéité du contenu des interventions et des protocoles d'étude. Cette hétérogénéité limitait la transférabilité des bonnes pratiques et entraînait une grande méfiance à l'égard des INM de la part des professionnels, des usagers et des opérateurs de santé. L'étude a consisté à co-construire un cadre consensuel d'évaluation des INM, qui réponde à la fois aux spécificités de ces pratiques de santé et aux standards internationaux de la recherche dans le domaine de la santé.MéthodeL'étude a impliqué l'ensemble des acteurs concernés en France, académiques et non académiques, chercheurs, usagers, professionnels de la prévention et du soin, opérateurs de santé, sociétés savantes et autorités de santé. Le cadre a été co-construit sous la direction d'un comité pluridisciplinaire de 22 experts par des échanges itératifs, ouverts et suivis, en quatre étapes successives: travaux en comité restreint, travaux en comité élargi, vote ouvert par collège, et consultation des autorités de santé et des sociétés savantes.RésultatsLe cadre d'évaluation des INM, appelé "modèle NPI", comprend 14 invariants éthiques et 63 invariants méthodologiques répartis entre cinq types d'études : mécaniste, observationnelle, prototypique, interventionnelle/clinique et d'implémentation. Il a reçu le soutien de 28 sociétés savantes et de 3 autorités de santé françaises.ConclusionLa création d'un cadre standardisé d'évaluation des INM pour le système de santé français présente plusieurs avantages: (1) il harmonise et clarifie les attentes épistémologiques, méthodologiques et éthiques des études évaluant les INM pour les chercheurs et promoteurs d'études; (2) il assure une meilleure transférabilité des résultats des études pour une meilleure garantie des bénéfices sur la santé et une meilleure sécurité des pratiques; (3) il garantit l'efficience des programmes pour les professionnels des secteurs de la santé, de la prévention et de l'accompagnement; (4) il assure la mise en oeuvre de pratiques efficaces et sûres pour les usagers; (5) il contribue à une meilleure compréhension des INM par les décideurs et les régulateurs; (6) il assure une meilleure traçabilité des INM pour les opérateurs de santé; (7) il fournit des solutions intégrables dans les stratégies de financement des systèmes d'assurance et de solidarité sociale.</p>
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